1. Patients undergoing maintenance hemodialysis experienced fewer serious adverse events if treated proactively with high-dose intravenous iron sucrose compared to patients reactively treated with low-dose iron sucrose.
2. Higher doses of erythropoiesis-stimulating agents were utilized more in the low-dose iron group compared to the high-dose group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Maintenance hemodialysis increases blood loss and reduces iron absorption, putting patients at risk for anemia. Intravenous iron administration is now utilized to counteract iron loss in hemodialysis patients, though what dose is optimal is presently unknown. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTOL) trial sought to determine if proactive high-dose or reactive low-dose iron therapy would be safer in terms of minimizing serious adverse events, with results indicating patients in the high-dose group experienced fewer major adverse events. Additionally, erythropoiesis-stimulating agents were utilized less in the high-dose group, and infection rates were similar between groups.
This large randomized trial provides substantial evidence for supporting an optimal-dose treatment regimen involving important aspects of both safety and efficacy of iron treatment for hemodialysis patients. Its open-label design and lack of more dosing levels limits its results, though the long-term follow-up is a substantial strength.
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